Melanoma Brain MetastasesPhase 1/2BETTERNCT06163820
Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases
A Phase 1/2 study testing Bevacizumab, Ipilimumab and Nivolumab in people with Melanoma Brain Metastases, run by Melanoma and Skin Cancer Trials Limited at 1 site in Australia.
Trial summary
Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Brain Metastases
- What is being tested?
- Bevacizumab, Ipilimumab and Nivolumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Aug 2026to 30 Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histologically (or cytologically) proven metastatic melanoma, with radiologically confirmed brain metastases.
- 2. Symptomatic from brain metastases at the time of study enrolment, or brain metastases that requires corticosteroids for the management of neurological symptoms.
- 3. Intracranial lesions amenable to hypofractionated stereotactic radiotherapy. These are defined as all intracranial melanoma lesions greater or equal to 5 mm in diameter, all intracranial lesions that are causing symptoms, and all intracranial lesions located in the eloquent areas of the brain.
- 4. World Health Organisation (WHO) performance status of 0 - 2
- 5. At least one brain metastasis has to be symptomatic.
- 6. Laboratory tests required: Haemoglobin (Hb) ≥ 9.0 g/dL Absolute neutrophil count ≥ 1 x 109/L Platelet count ≥ 100 x 109/L Either: Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (Patients with isolated hyperbilirubinaemia due to Gilbert's syndrome are allowed.) Or: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x (ULN) unless raised due to tumour in which case up to 5 x ULN is permissible Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault or MDRD are acceptable)
- 7. Age ≥ 18 years
- 8. Able to provide informed written consent (signed and dated), attend trial site for study visits and be capable of co-operating with treatment and follow-up
Who cannot join
- 1. Prior radiotherapy to the brain
- 2. Active concurrent malignancy requiring systemic anti-cancer therapy within the last 2 years. Patients with any malignancy treated with curative intent and no evidence of disease will be eligible for this trial.
- 3. Prior systemic therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for extracranial disease only, completed more than >6 months prior to enrolment in this trial and if administered with radiological proof of the absence of brain metastases
- 4. Inability to undergo MRI of the brain
- 5. Definitive leptomeningeal disease. Patients with equivocal leptomeningeal disease may be included on the trial after discussion with CPI.
- 6. Female patients who are pregnant or lactating. Patients who are able to become pregnant, must return a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom] or agree to sexual abstinence, effective from signing the consent form, throughout the trial and for six months after any treatment for melanoma, radiotherapy or immunotherapy, are considered eligible.
Show all 25Show fewer
- 7. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception or to sexual abstinence effective from the first administration of bevacizumab, throughout the trial and for six months afterwards after treatment the end-of-trial visit. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception to prevent exposure of the foetus or neonate. Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- 8. Haemorrhage encompassing >50% of any lesion that is >10 mm in diameter (excluding surrounding oedema). A modern susceptibility-sensitive MRI sequence such as SWI is mandatory.
- 9. Brain metastases greater than 5 cm in maximal diameter
- 10. Increasing corticosteroid dose for 48 hours prior to initiation of study therapy OR current dexamethasone-equivalent dose of >8 mg per day
- 11. Major thoracic or abdominal surgery within 28 days prior to initiation of trial treatment
- 12. Neurosurgery within 14 days prior to initiation of trial treatment
- 13. Active or history of severe auto-immune disease requiring systemic anti-inflammatory therapy. Patients with well-controlled auto-immune diseases not requiring systemic anti-inflammatory therapy may be included after consultation with the CPI. Severe auto-immune respiratory disease will be excluded from the trial.
- 14. History of inflammatory bowel disease
- 15. Requirement for ongoing concurrent systemic immunosuppressive therapy (other than corticosteroids).
- 16. History of intra-abdominal inflammatory process within 6 months prior to initiation of trial treatment, including but not limited to peptic ulcer disease, diverticular disease or colitis.
- 17. History of abdominal or trachea-oesophageal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to initiation of trial treatment
- 18. History of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration, parenteral nutrition or tube feeding within 6 months prior to initiation of trial treatment
- 19. Any Grade ≥3 haemorrhage or bleeding event within 28 days of trial treatment initiation. Patients presenting with haemorrhagic brain metastases that have been adequately treated with neurosurgery are not excluded under this criterion but remain subject to criterion 12 pertaining to timing of neurosurgery.
- 20. Current use of full-dose anticoagulation or thrombolytic therapy within 10 days of initiation of trial treatment
- 21. Evidence of bleeding diatheses or significant coagulopathy
- 22. History of inadequately controlled arterial hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg despite maximal medical therapy); prior history of hypertensive crises or hypertensive encephalopathy
- 23. Concurrent congestive heart failure, prior history of NYHA class III/ IV cardiac disease, prior history of cardiac ischaemia or prior history of cardiac arrhythmia
- 24. Concurrent participation in another interventional clinical trial or intention to do so. Concurrent participation in an observational trial is acceptable.
- 25. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Alfred Health
Melbourne, Victoria, 3004
Sally Haines, BNurs. GradCert (Pall.Care), 03 9076, S.Haines@alfred.org.au
Dr Malaka Ameratunga
About this study
Official title: Bevacizumab and Immune chEckpoint Inhibitors Plus Hypofractionated Stereotactic radioTherapy for the Treatment of sympTomatic mElanoma bRain Metastases.
Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM).
Read the detailed description
Despite significantly improved clinical outcomes for patients with metastatic melanoma, the subset of patients with symptomatic MBM still fare poorly with treatment. The current standard of care for this group of patients is combined immune checkpoint blockade with ipilimumab and nivolumab, with local treatment with neurosurgery or stereotactic radiotherapy added for larger/more symptomatic lesions.
Bevacizumab has demonstrated evidence in the treatment of cerebral radiation necrosis and in a case series, promising symptomatic benefit in this group of patients. With strong empirical evidence of the ability to wean patients from steroids, mechanistically, bevacizumab may augment anti-tumour immunity from immune checkpoint blockade.
Bevacizumab will be administered 7 days prior to combination immunotherapy with ipilimumab and nivolumab and then given 28 days later to coincide with the second cycle of ipilimumab and nivolumab and thereafter every 3 weeks. The starting dose will be 7.5mg/kg, given intravenously, for a total of four cycles, and is consistent with the existing literature on the treatment of cerebral radiation necrosis.
This trial aims to determine the safety of bevacizumab, in combination with ipilimumab, nivolumab and hSRT, defined as no more than 1/6 patients experiencing a bevacizumab-related SAE in the initial phase of the study.
- Conditions
- Melanoma Brain Metastases
- Being tested
- Bevacizumab, Ipilimumab, Nivolumab, Hypofractionated stereotactic radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab is a humanised monoclonal antibody with molecular weight 167kD that inhibits all isoforms of the vascular endothelial growth factor (VEGF) and is produced from a Chinese hamster ovary mammalian system. It has high specificity for isoform-A and has a half-life of ~21 days.
IpilimumabDrug
Also called Yervoy
Ipilimumab is an immune checkpoint inhibitor (ICI) that targets anti-tumour immunity. Ipilimumab is a recombinant human immunoglobulin monoclonal antibody that binds CTLA4 and blocks the interaction between CD80/86 and CTLA4.
NivolumabDrug
Also called Opdivo
Nivolumab ia an immune checkpoint inhibitor (ICI) that targets anti-tumour immunity. Nivolumab is a fully human monoclonal IgG4 antibody targeting PD-1 which demonstrates activity across a range of tumours.
Hypofractionated stereotactic radiotherapyRadiation
Hypofractionated stereotactic radiotherapy (hSRT) will be delivered to previously untreated brain metastases in eligible participants. hSRT will be delivered to all symptomatic brain metastases, all brain metastases >1 cm and all brain metastases located in eloquent areas of the brain. hSRT will be commenced after the first cycle of nivolumab plus ipilimumab and completed before the second cycle of nivolumab plus ipilimumab. hSRT should be commenced within 1 week from the planning MRI.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will receive the following:
1. Bevacizumab 7.5 mg/kg every 3 weeks for 4 cycles
2. Nivolumab 1 mg /kg + ipilimumab 3 mg/kg every 3 weeks for 4 cycles (induction phase) followed by nivolumab monotherapy at 480mg every 4 weeks (maintenance phase)
3. hSRT (24-27Gy/3# or 25-30Gy/5#) Receives: Drug: Bevacizumab; Drug: Ipilimumab; Drug: Nivolumab; Radiation: Hypofractionated stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of bevacizumab, in combination with ipilimumab, nivolumab and hSRT
Number of participants with bevacizumab-related SAEs. A dose-limiting toxicity rate of <33% with a minimum of 3 patients treated will be considered safe.
Measured: 5 years
Secondary outcomes (7)
Determining the magnitude in reduction in prednisolone equivalent dose (relative to baseline dose)
The combination of a strict patient diary of corticosteroid dose, volumetric analysis of oedema on paired MRI samples with Peripheral blood mononuclear cells (PBMCs) to delineate immune cell subsets will allow proof-of-mechanism to be demonstrated.
Specifically, if the proposed combination demonstrates preliminary activity, we will be able to demonstrate that this activity corresponds to a decrease in steroid dose (diary) which is permissible due to reduced oedema (volumetric analysis), resulting in augmented antitumour immunity (as evidence by increased peripheral antitumour immune cells). Finally, the inclusion of a health-related quality of life (QoL) analysis in this early phase clinical trial, may demonstrate that the reduction in steroid dose is clinically meaningful to patients.
Measured: 2 years
Intracranial clinical benefit
The rate of intracranial clinical benefit, defined as the percentage of patients who had stable disease for at least 6 months after the initiation of treatment, complete response (CR), or partial response (PR)
Measured: 5 years
Response rate
The rate of overall response (defined as the rate of complete or partial response)
Measured: 5 years
Progression-free survival
The rate of intracranial, extracranial (systemic), and global progression-free survival (PFS)
Measured: 5 years
Overall survival
Overall survival
Measured: 5 years
Volume of vasogenic oedema
Determining the magnitude in reduction of the volume of vasogenic oedema around the brain metastases on MRI scan, after the administration of bevacizumab
Measured: 2 years
To assess the patient-rated quality of life by the mean change from baseline quality of life scores [QLQ-C30] to the time of response, stable disease or progression.
We will assess utility-based health-related quality of life (HRQoL) of the combination of bevacizumab, with ipilimumab plus nivolumab, and hSRT using scores from the EORTC QLQ-C30 instrument transformed to QLU-C10D algorithm at baseline and 6-weekly for 6 months, then 12 weekly thereafter to identify resultant improvements in patients' QoL. In addition, the utility indices will be used to estimate quality-adjusted life years (QALYs).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start31 Aug 2026
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The trial is a phase I/II, single arm, unblinded, multi-centre dose de-escalation trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT).
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melanoma and Skin Cancer Trials Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malaka Ameratunga, Study chair, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163820
- Sponsor's protocol ID
- 05.21 BETTER
- Acronym
- BETTER
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab and Immune chEckpoint Inhibitors Plus Hypofractionated Stereotactic radioTherapy for the Treatment of sympTomatic mElanoma bRain Metastases.
- ClinicalTrials.gov ID
- NCT06163820
- Acronym / sponsor ID
- BETTER / 05.21 BETTER
- Conditions
- Melanoma Brain Metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Melanoma and Skin Cancer Trials LimitedUniversity, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM).
Detailed description
Despite significantly improved clinical outcomes for patients with metastatic melanoma, the subset of patients with symptomatic MBM still fare poorly with treatment. The current standard of care for this group of patients is combined immune checkpoint blockade with ipilimumab and nivolumab, with local treatment with neurosurgery or stereotactic radiotherapy added for larger/more symptomatic lesions.
Bevacizumab has demonstrated evidence in the treatment of cerebral radiation necrosis and in a case series, promising symptomatic benefit in this group of patients. With strong empirical evidence of the ability to wean patients from steroids, mechanistically, bevacizumab may augment anti-tumour immunity from immune checkpoint blockade.
Bevacizumab will be administered 7 days prior to combination immunotherapy with ipilimumab and nivolumab and then given 28 days later to coincide with the second cycle of ipilimumab and nivolumab and thereafter every 3 weeks. The starting dose will be 7.5mg/kg, given intravenously, for a total of four cycles, and is consistent with the existing literature on the treatment of cerebral radiation necrosis.
This trial aims to determine the safety of bevacizumab, in combination with ipilimumab, nivolumab and hSRT, defined as no more than 1/6 patients experiencing a bevacizumab-related SAE in the initial phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial is a phase I/II, single arm, unblinded, multi-centre dose de-escalation trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Bevacizumab, Drug: Ipilimumab, Drug: Nivolumab, Radiation: Hypofractionated stereotactic radiotherapyPatients will receive the following: 1. Bevacizumab 7.5 mg/kg every 3 weeks for 4 cycles 2. Nivolumab 1 mg /kg + ipilimumab 3 mg/kg every 3 weeks for 4 cycles (induction phase) followed by nivolumab monotherapy at 480mg every 4 weeks (maintenance phase) 3. hSRT (24-27Gy/3# or 25-30Gy/5#) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Histologically (or cytologically) proven metastatic melanoma, with radiologically confirmed brain metastases.
- 2. Symptomatic from brain metastases at the time of study enrolment, or brain metastases that requires corticosteroids for the management of neurological symptoms.
- 3. Intracranial lesions amenable to hypofractionated stereotactic radiotherapy. These are defined as all intracranial melanoma lesions greater or equal to 5 mm in diameter, all intracranial lesions that are causing symptoms, and all intracranial lesions located in the eloquent areas of the brain.
- 4. World Health Organisation (WHO) performance status of 0 - 2
- 5. At least one brain metastasis has to be symptomatic.
Key exclusion criteria (25 listed)
- 1. Prior radiotherapy to the brain
- 2. Active concurrent malignancy requiring systemic anti-cancer therapy within the last 2 years. Patients with any malignancy treated with curative intent and no evidence of disease will be eligible for this trial.
- 3. Prior systemic therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for extracranial disease only, completed more than >6 months prior to enrolment in this trial and if administered with radiological proof of the absence of brain metastases
- 4. Inability to undergo MRI of the brain
- 5. Definitive leptomeningeal disease. Patients with equivocal leptomeningeal disease may be included on the trial after discussion with CPI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab is a humanised monoclonal antibody with molecular weight 167kD that inhibits all isoforms of the vascular endothelial growth factor (VEGF) and is produced from a Chinese hamster ovary mammalian system. It has high specificity for isoform-A and has a half-life of ~21 days. | Drug | Intervention |
| IpilimumabAlso: YervoyIpilimumab is an immune checkpoint inhibitor (ICI) that targets anti-tumour immunity. Ipilimumab is a recombinant human immunoglobulin monoclonal antibody that binds CTLA4 and blocks the interaction between CD80/86 and CTLA4. | Drug | Intervention |
| NivolumabAlso: OpdivoNivolumab ia an immune checkpoint inhibitor (ICI) that targets anti-tumour immunity. Nivolumab is a fully human monoclonal IgG4 antibody targeting PD-1 which demonstrates activity across a range of tumours. | Drug | Intervention |
| Hypofractionated stereotactic radiotherapyHypofractionated stereotactic radiotherapy (hSRT) will be delivered to previously untreated brain metastases in eligible participants. hSRT will be delivered to all symptomatic brain metastases, all brain metastases >1 cm and all brain metastases located in eloquent areas of the brain. hSRT will be commenced after the first cycle of nivolumab plus ipilimumab and completed before the second cycle of nivolumab plus ipilimumab. hSRT should be commenced within 1 week from the planning MRI. | Radiation | Intervention |
Primary outcome
To determine the safety of bevacizumab, in combination with ipilimumab, nivolumab and hSRT
Time frame: 5 years
Number of participants with bevacizumab-related SAEs. A dose-limiting toxicity rate of <33% with a minimum of 3 patients treated will be considered safe.
7 secondary outcomes
Determining the magnitude in reduction in prednisolone equivalent dose (relative to baseline dose)
Time frame: 2 years
Intracranial clinical benefit
Time frame: 5 years
Response rate
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Volume of vasogenic oedema
Time frame: 2 years
To assess the patient-rated quality of life by the mean change from baseline quality of life scores [QLQ-C30] to the time of response, stable disease or progression.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Melanoma Brain Metastases
RecruitingPhase 2
Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)
Melanoma Stage Iv
Active, not recruiting
Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial
Brain Metastases
RecruitingPhase 1/2
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype
Active, not recruitingPhase 3
Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Treating Patients With Newly Diagnosed Non-melanoma Brain Metastases
Metastatic Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
RecruitingPhase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Acral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malaka Ameratunga study chair
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab, Ipilimumab and Nivolumab in people with Melanoma Brain Metastases, run by Melanoma and Skin Cancer Trials Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katja Loewe (+61399039022, better@masc.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety of bevacizumab, in combination with ipilimumab, nivolumab and hSRT (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.